Clearance Summary
DRG REACTION CHAMBER/SAFETY TIP received FDA 510(k) clearance under submission number K012003, sponsored by Doctor'S Research Group, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-02-12.
- Submission: K012003
- Applicant / Sponsor: Doctor'S Research Group, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2002-02-12
Classification & Regulation
This clearance is catalogued under FDA product code HEI and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.